Claiming Clones

This case relates to Dolly, probably the most famous baby sheep ever.1 As most folks know, Dolly was the first successful mammalian clone from an adult somatic cell. This means that her nucleic genetic material is a copy of the adult from which she was cloned. The basic process used to create Dolly is illustrated to the right.

In addition to claims on the cloning process (which were not at issue in this appeal), the University of Edinburgh also sought product claims. Claims 155 and 164 are representative:

155. A live-born clone of a pre-existing, nonembryonic, donor mammal, wherein the mammal is selected from cattle, sheep, pigs, and goats.
164. The clone of any of claims 155-159, wherein the donor mammal is non-foetal.

The Patent Office rejected these claims on Section 101, 102, and 103 grounds and the University appealed.

The Federal Circuit agreed that the claims were not patent eligible under Section 101. The court began by distinguishing Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948) (which it treated as a subject matter eligibility case) from Diamond v.Chakrabarty, 447 U.S. 303, 309 (1980), with the latter involving a patent eligible organism because “it was ‘new’ with “markedly different characteristics from any found in nature and one having the potential for significant utility.” Slip Op. at 6, quoting Chakrabarty at 310 (emphasis added by court). On the other hand, “any existing organism or newly discovered plant found in the wild is not patentable.” Id. at 6-7. Association for Molecular Pathology v. Myriad Genetics,Inc., reinforced this distinction. 133 S. Ct. 2107 (2013)

Here, the claims covered organisms (such as Dolly) that do not “possess ‘markedly different characteristics from any [farm animals] found in nature.'” Slip Op. at 7, quoting Chakrabarty. The emphasis of the court’s analysis was on genetic identity: “Dolly’s genetic identity to her donor parent renders her unpatentable.” Id. The claims thus fell into the product of nature exception to the broad scope of patent eligible subject matter.

Underlying the court’s opinion was a policy thread relating to copying generally: that the copying of unpatentable articles is permitted so long as it does not infringe a patented method of copying. In Sears Roebuck & Co. v. Stiffel Co., for example, the Supreme Court wrote that “[a]n unpatentable article, like an article on which the patent has expired, is in the public domain and may be made and sold by whoever chooses to do so.” 376 U.S. 225, 231 (1964). Because the claimed clones are exact genetic copies of the of patent ineligible subject matter, they, too, are not eligible for patent protection.

What about the argument that these clones may be genetic copies of the donor organism, but they aren’t exactly the same? For example, environmental factors will produce differences between the phenotypes of the donor and clones and their mitochondrial DNA will differ, since the mitochondrial DNA comes from a different source than the nucleic DNA. The court rejected these arguments because such differences were not claimed: the claims are written in terms of genetic identity, not phenotypic or mitochondrial differences.

What the court appears to be implicitly doing here is to interpret the claims in a manner that is least favorable to the applicant. There is at least a plausible argument that the claims do implicate genetic identity but phenotypic diversity by their reference to a “live-born clone of a … mammal.” To be sure, the word “clone” contemplate genetic identity. But at the same time the very idea of a live-born mammalian clone suggests that the product will not be an exact duplicate of the donor. In other words, while the claims don’t contain the words “phenotypic difference,” those differences are inherent in what a clone is: a clone will necessarily exhibit phenotypic differences because it will develop in different environmental circumstances than its donor.

However, even were the claims to expressly include such limitations, the court reasoned that it would not change the outcome. As to phenotypic differences, they “do not confer eligibility on their claimed subject matter. Any phenotypic differences between Roslin’s donor mammals and its claimed clones are the result of ‘environmental factors,’ Appellant’s Br. 21, uninfluenced by Roslin’s efforts.” Slip Op. at 10. (I guess the fact that the whole process was set in motion by human activity doesn’t count). As to mitochondrial differences, “There is nothing in the claims, or even in the specification, that suggests that the clones are distinct in any relevant way from the donor animals of which they are copies.” Id. at 11. As a result, the claims fail the “markedly different characteristics” language of Chakrabarty.

70 thoughts on “Claiming Clones”

Does anyone know whether Roslin Institute also had claims to the clone via a product-by-process claim? This type of claim would have the mtDNA difference implied into the claim and perhaps would be enough to get over the “markedly different” hurdle.

From a purely equitable point of view, the court made the right decision here. Regardless of the intent of cases like Chakrabarty and Funk Bros.

Also, I cannot believe the author brought up phenotypical variations as if that had any meaning. I could take a natural born baby and expose it to all sorts of conditions that would affect its phenotype.

Not having access to the file wrapper history of this application, I wonder why the claims in question were not rejected as anticipated or obvious from the 70 years or so of science fiction stories and scientific articles postulating that cloning of humans and animals was inevitable as processes of doing so were inevitably developed. The claims in question exhibit absolutely no novelty in view of the longstanding understanding that it would eventually be possible to clone animals or humans from “a pre-existing, nonembryonic, donor mammal” as claimed.

Looking for analogies, Jules Verne postulated preposterous ways of submarine and lunar exploration. Flying machines were proposed by Leonardo and many others prior to the Wright Brothers’ success. All of the inventions that have made submerged, atmospheric and space locomotion possible claim the actual mechanisms, materials, and methods that make the same possible – not the bare idea of doing so. Why? Because that was the prior art starting point from which the invention was realized.

These cloning claims express absolutely nothing that would make cloning possible. They express no advance in the art over speculation about the possibility of cloning. The inventors in this application only deserve claims to novel and non-obvious methods and apparatus used to make animal cloning possible. Perhaps other claims reciting the same have have been allowed to them.

Again, I have not looked at the entire history of the applications in issue and perhaps there are answers to my question – why were these claims not rejected under 102 and 103 and why are those rejections not on appeal?

An exact genetic copy of a living mammal is, itself, something that is not found in nature. The original mammal is found in nature but the genetic copy is not. Thus a claim to the clone should have survived the 101 test.

Isaac: The original mammal is found in nature but the genetic copy is not.

“The original light bulb existed in Edison’s laboratory but the exact copy did not.”

This is a very poor argument for granting a patent on a “copy” of anything, whether it’s a living creature, a chemical or a kitchen appliance. The proper protection for a new method of copying something that already exists is found in a method claim.

There is a deep problem with the “product of nature” exception to subject matter eligibility generally which is that human beings and everything they create are no more or less “natural” than anything else in the universe. The same physical laws apply to all non-abstract, non-virtual and non-imaginary objects.

Put another way, it’s not clear to me why there should be a different analysis for examining a claim in view of an old “man-made” composition and an old “natural” composition. Both the old compositions are in the public domain. Why should it make any difference if one of the old prior art compositions was, at some point, altered in some minute way by the “hand of man”?

“1. A live-born clone of a pre-existing, nonembryonic, nuclear dna donor mammal comprising nuclear dna identical to said nuclear dna donor mammal and comprising mitochondrial dna of an animal different than said nuclear dna donor mammal.”

Do we need to start being careful to define and designate whether the term clone refers to ndna, mtdna, or both?

In any event, the animal claimed above could be useful. Let’s say it’s “Molly” the sheep and Molly has truly fantabulous wool. But alas, poor Molly is subject to nasty metabolic disorders inherited from her mum’s mtDNA.

We use Folly the sheep’s egg and Molly’s teat cells to clone and viola, we get great woolly clones less the nasty metabolic disorders?

Do we need to start being careful to define and designate whether the term clone refers to ndna, mtdna, or both?

You need to continue being careful to describe your compositions using structural terms that distinguish those compositions from prior art compositions.

The claims in Roslin were poorly drafted. Trying to rely on “source limitations” to protect your valuable invention is something you do if you’re incompetent and/or you wish to diminish the potential value of your patent.

I’m not talking about patent law, just ordinary usages of the term clone itself by those in the industry. For example, is an organism that uses a donor’s exact mitochondrial dna, but has regular (not cloned) nuclear dna, still viewed as some sort of “clone” for having identical mitochondrial dna?

And I’m asking the question just because I’m ignorant and don’t know what the common usage is these days.

On the whole the decision is reasonable because of the test of novelty + different characteristics + new utility which comes from Chakrabarty.

But what is problematic is the acknowledgement of Funk Brothers as an eligibiliity test rather than its correct classification under the unobviousness heading using the now superseded test of inventove genius. A detailed paper was submitted to the USPTO this morning in advance of the natural product patent eligibility guidelines for natural products this afternoon. If anyone would like a copy please e-mail me at pcole@lucas-uk.com

Paul, when considering a “product” claim that includes ineligible subject mater, where the courts have consistently suggested or held that new and useful processes involved in extracting or using such products are the eligible, see, e.g., Wood Paper Patent and Funk Bros. , how does one distinguish between a claim to a product that preempts the ineligible product from a claim that does not?

“Markedly different” is one such test — laid down by Hand and adopted by Chakrabarty. But “markedly different” actually is a test of “invention” that was in use by the courts prior to 1952. It has been superseded by §103. But while a test under §103 should not consider ineligible subject matter when determining obviousness, the Supreme Court has held in Prometheus that the test should not be conducted under §103, but under §101, essentially because there is no statutory basis in §103 for excluding ineligible subject matter from consideration.

So when you say that Funk Brothers is really a determination that should be made under §103, I might agree with you but for Prometheus. But because of that case we can no longer simply ignore ineligible subject matter in making the determination of obviousness under that statute.

Thus to your suggestion to the PTO that we should somehow ignore Funk Brothers can only lead to confusion. When one is dealing with a product claim that includes ineligible subject matter, the test for nonobvious subject matter must be conducted under §101 according to the Supreme Court. And according to Funk Brothers, the difference between the claimed subject matter and the prior art that forms the basis for the test of obviousness (invention) cannot include the ineligible.

““Markedly different” is one such test — laid down by Hand and adopted by Chakrabarty. But “markedly different” actually is a test of “invention” that was in use by the courts prior to 1952. It has been superseded by §103.”

Chakrabarty was post 1952. Chakrabarty did not use 103.

Do not conflate (lol, if you can, and even if it appears that the Court does – as they say they do not).

Now, do you realize where the blame for all of this 101 mess truly lies?

The mess is clearly and incontrovertibly linked to the Court trying to maintain its addiction to the 101 nose of wax.

That is why the CAFC threw up its hands in Alice and smacked the Supreme Court across the face with the leather gloves of “you made this mess – you solve this mess.”

Correctly decided (a seeming rarity for the Fed Cir these days) but frankly I would have enjoyed seeing them wrong on this one, if only to see the eventual decision holding 101 unconstitutional which would result.

The novel, the Windup Girl, is about a future where genetic engineering has all but destroyed the planet. But they have engineered humans. These are engineered to have jerky movements like windup dolls. They are treated as machines by their owners. They have no rights and can be disposed of like trash.

I agree. And, the author’s parenthetical, and seemingly sarcastic remark: “(I guess the fact that the whole process was set in motion by human activity doesn’t count)” misses the mark. The claim is NOT to the process. Proper claims, in this case, should be to the method/process, IMO.

As to mitochondrial differences, “There is nothing in the claims, or even in the specification, that suggests that the clones are distinct in any relevant way from the donor animals of which they are copies.”

While I’m sure the court was rooting around in the dark in arriving at this statement, it is true that the claims encompass clones formed by using a donor egg cell from the same animal that the donor DNA came from, in which case the mitochondrial DNA would be identical as well.

I’ve got to agree with you that these claims, whether product-by-process or otherwise, are poorly drafted if you’re trying to recite what’s “unique” in the cloned animal. Unless Dyk is “making it up,” the applicant here never did put the features which it argued on appeal were unique into the claim(s). That’s not going to cut it in view of the “new” language” in 35 USC 101.

But is not what is new inherent in the claim? If one reads the claim as a person having ordinary skill in the art to which the invention pertains, the word ‘clone’ itself, informed by the specification, already contains these minute differences being advanced by several readers here. It is just a matter that those minute differences make no effective difference. You are basically trying to claim a(n exact enough) copy of something already freely available to all – in the patent sense.

I think the problem is not a problem that “new” was not claimed, but rather, what was claimed (including inherency) was in fact an attempt to claim merely a “new version” of something already in the warehouse of man, meant to be free to all and outside of the dominion of patent law.

That’s precisely why product-by-process claims exist. To allow things made by a new process to be claimed, even if the things were previously made by some other process. There is nothing wrong with 155 and 164.

I think the court’s discussion of Myriad is give too short a shrift which relied heavily and exclusively on “new” and not on “markedly difference characteristics.”

As a result, the court left open a door that Myriad seemingly slammed shut with emphasis: that the claimed composition can be identical with that found in nature and nevertheless be eligible.

Thus, this statement is utterly confusing:

“The clones are defined in terms of
the identity of their nuclear DNA to that of the donor
mammals. To be clear, having the same nuclear DNA as
the donor mammal may not necessarily result in patent
ineligibility in every case. Here, however, the claims do
not describe clones that have markedly different characteristics
from the donor animals of which they are copies.”

Ned: the court left open a door that Myriad seemingly slammed shut with emphasis: that the claimed composition can be identical with that found in nature and nevertheless be eligible.

I’m having difficulty following this, Ned. Is the part after the colon the open door or the shut door?

this statement is utterly confusing: “The clones are defined in terms of the identity of their nuclear DNA to that of the donor mammals. To be clear, having the same nuclear DNA as the donor mammal may not necessarily result in patent ineligibility in every case.

The Federal Circuit is simply making a trivial point here: the mere fact that a claimed man-made has (or might have) the same nuclear DNA as another organism is not sufficient to decide the eligibility of the claim. There are literally an infinite number of different examples I could give you but the following claims would certainly be eligible.

where the claim is not to the composition found in nature, but to something else that includes a composition found in nature, then perhaps we get into the markedly different characteristics realm.

Every composition includes “a composition found in nature.” Nature is everywhere. Or maybe you are referring to “Nature’s Warehouse,” that magical mystical place that turns up every now and then when jurists or blog commenters use that fancy meaningless phrase to make themselves sound serious (to their own ears)?

1. A inoculant comprising a species of bacteria of the genus Rhizobium that is mutually non-inhibitive of strains of different species of bacteria of the genus Rhizobium.

The composition claimed is found in nature. It functional limitation should be given no weight, in my view.

You can give the functional limitation all the weight you want. Just because you discover a new property of an old composition (“natural” or otherwise) doesn’t mean you get to patent it all over again. That’s basic, fundamental stuff.

And anyone who argues that you need to carry out that “function” or perform some test to infringe that claim is either deeply confused about the difference between method and composition claims, or he/she is intentionally trying to create such confusion (I’ll let you guess why someone might try to do that).

I have seen no such things here. I have seen arguments on a different topic/angle that appear to have been spun to reach your new statement, though. Perhaps you can provide a little more detail as to when and where you have seen “people trying to make such arguments,” we all can place your comment in a proper context.

If you’re interested, I can send you my first law review (published in 1978 in the Richmond Law Review) which discussed the patent-eligibility of “living subject matter,” including In re Bergy and In re Chakrabarty (yes, my article came out before Diamond v. Chakrabarty).